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NCT01416922 Clinical Trial

oncoFISH Cervical Test for Detection of 3q26 Region Gain

Cervical Cancer Clinical Trial

Official title:
The oncoFISH Cervical Test for Detection of 3q26 Region Gain

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT01416922
Other study ID # IKON 0801
Secondary ID
Status Enrolling by invitation
Phase N/A
First received August 12, 2011
Last updated August 12, 2011
Start date June 2009
Est. completion date December 2011

Study information
Verified date August 2011
Source Ikonisys, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The purpose of this study is to evaluate the use of the oncoFISH cervical test system in the management of women who have received an LSIL Pap report to determine whether the test can predict which women will progress to more serious cervical disease and which women do not have to be monitored as closely.

Other known NCT identifiers
  • NCT01417039

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 1100
Est. completion date December 2011
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 21 Years and older
Eligibility Inclusion Criteria:

- Women 21 years of age or greater with recent LSIL who are scheduled for colposcipal assessment.

- Women with previous or current STD or HIV may be included

- Women with previous LSIL history may be included.

Exclusion Criteria:

- pregnant women,

- women with vaginal intraepithelial lesions,

- women on a chemotherapeutic agent,

- women with previous or current cancer except for non-cervical squamous cell carcinoma

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Ikonisys New Haven Connecticut

Sponsors (1)
Lead Sponsor Collaborator
Ikonisys, Inc.

Country where clinical trial is conducted

United States, 

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